Alexandria

Researchers are evaluating the safety and effectiveness of rilvegostomig compared to pembrolizumab, both combined with platinum-based doublet chemotherapy, as initial treatments for patients with metastatic non-squamous non-small cell lung cancer (mNSCLC) whose tumors express PD-L1. This Phase III, randomized, double-blind, global study focuses on patients whose tumors meet the PD-L1 expression threshold of 1% or higher and do not have certain genetic mutations or rearrangements that would require other targeted therapies. Participants receive either rilvegostomig or pembrolizumab intravenously on the first day of each 21-day treatment cycle. Both groups also receive platinum-based chemotherapy drugs such as carboplatin or cisplatin, administered intravenously up to four cycles, along with pemetrexed given intravenously on Day 1 of each cycle. The study monitors these treatments as first-line therapy for metastatic non-squamous NSCLC. During the study, participants undergo regular assessments including imaging scans to measure tumor size and response, as well as evaluations of organ and bone marrow function. Researchers track overall survival and progression-free survival for up to approximately five years. Safety is closely monitored throughout, and patients are followed long-term to assess outcomes related to treatment effectiveness and tolerability.

This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line (1L) treatment for patients with squamous metastatic non-small cell lung cancer (mNSCLC) whose tumors express PD-L1 (tumor cells (TC) ≥ 1%).

Researchers are evaluating ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.

Researchers are evaluating whether adding zilovertamab vedotin to standard treatment helps people with previously untreated diffuse large B-cell lymphoma (DLBCL) live longer without their cancer growing or spreading. This Phase 3 study compares zilovertamab vedotin combined with rituximab plus cyclophosphamide, doxorubicin, and prednisone (R-CHP) against the standard regimen of rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP). The goal is to see if the new combination improves progression-free survival. Participants receive treatments through intravenous infusions of study drugs including zilovertamab vedotin, rituximab or its biosimilar, cyclophosphamide, doxorubicin, and vincristine, along with oral prednisone or prednisolone as per approved guidelines. Some may receive rescue medication such as granulocyte colony-stimulating factor (G-CSF) if needed. The study is open-label and conducted across multiple centers. During the study, participants are closely monitored for how long they live without their disease worsening, with follow-up up to approximately 50 months. Assessments include imaging scans like PET to evaluate disease status, heart function tests, and regular evaluations of overall health and side effects. Safety is monitored throughout, and researchers measure progression-free survival as the primary outcome to determine the effectiveness of the treatments.

Researchers are evaluating the effectiveness of riliprubart compared to a placebo in adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) whose disease has not responded to standard treatments. This is a Phase 3, double-blind, placebo-controlled study focusing on participants with refractory CIDP, including typical and variant forms such as motor CIDP and multifocal CIDP. The study aims to assess response rates over time to better understand the potential benefits and safety of riliprubart for this condition. Participants will receive either riliprubart or placebo administered as a solution via intravenous infusion or subcutaneous injection. The treatment period includes multiple phases with dosing and monitoring planned through 48 weeks. The study includes a screening phase, treatment phases, and follow-up extending up to a total of 111 weeks. Both groups will be monitored for lasting treatment responses, with specific attention to changes from baseline to weeks 24 and 48. During the study, participants will undergo regular assessments to track their disease activity and response to treatment. Evaluations include clinical scoring using the INCAT and CIDP disease activity scores, documentation of vaccinations, and monitoring for adverse effects. Researchers will measure the percentage of participants showing a treatment response and those maintaining that response over time, while also ensuring participant safety through ongoing follow-up and clinical evaluations throughout the study duration.

Researchers are establishing the Caris Biorepository to collect and store high-quality biological specimens along with clinical and demographic data. This resource aims to support research studies focused on advancing precision medicine and improving patient care, especially in areas related to cancer, early detection of cancer, and minimal residual disease. The biorepository is designed to securely share valuable biospecimen information and clinical outcomes to help develop targeted treatments and improve healthcare. The Caris Biorepository will gather specimens prospectively from multiple sources and maintain molecular integrity and clinical relevance of these samples. It will provide access to this information for researchers both within Caris Life Sciences and external collaborators such as government agencies, academic institutions, and industry partners. The project supports drug development, clinical research trials, publications, and healthcare policy development by bridging the gap between human specimens and associated clinical data. Participants in this research will provide biospecimens and clinical data, with the biorepository managing access and use of these materials over time. The study focuses on developing a high-quality collection of human samples and associated data for up to 35 years, supporting various research purposes. Outcomes include ensuring specimen integrity and releasing specimens for testing while maintaining detailed clinical information to facilitate future medical discoveries and improvements in patient outcomes.

Researchers are evaluating the effectiveness of NeoThelium FT combined with standard care compared to standard care alone in treating diabetic foot ulcers. This open-label, randomized controlled crossover trial involves patients with chronic diabetic foot ulcers and aims to assess wound healing within 12 weeks. The study is conducted across multiple medical centers and includes a crossover option for patients not healed after initial treatment with standard care alone. Participants are randomly assigned to either standard care, which includes wound cleansing, debridement, moisture-balancing dressings, and offloading, or to standard care plus weekly applications of NeoThelium FT, a dual-layer membrane derived from donated human placental tissue. Those in the standard care group who do not achieve complete wound closure by about 84 days may cross over to receive NeoThelium FT weekly for up to 12 visits while continuing scheduled follow-up. Before randomization, all participants undergo a two-week screening phase. During the study, researchers will monitor wound closure rates, time to closure, wound area reduction, and pain. Assessments include measuring wound healing progress and ensuring ulcers remain free of infection. The study supports data collection for insurance reimbursement decisions and includes safety monitoring throughout the treatment and follow-up periods.

Researchers are collecting prospective data from patients receiving various pain management treatments for chronic knee osteoarthritis (OA) pain or pain control around the time of knee replacement surgery. The study aims to capture information on several pain therapies such as cryo nerve block, radiofrequency ablation, intra-articular corticosteroids, viscosupplementation, opioids, and non-steroidal anti-inflammatory drugs (NSAIDs). This registry is designed to understand the outcomes and effects of these treatments in real-world settings for knee OA patients. Participants will receive pain management treatments for knee OA, which may involve knee injections, nerve blocking procedures, or knee replacement surgery planned within 60 days of screening. The study collects data over an 18-month period, monitoring various aspects related to pain intensity, opioid use, functional status, sleep quality, and adverse events. Treatments are delivered as part of standard care and recorded through this registry to evaluate their outcomes. During the 18 months of participation, patients will complete questionnaires through a smartphone or internet-enabled device to report pain levels, functional abilities, sleep disturbance, quality of life, satisfaction, physical therapy use, and work productivity. Researchers will also track emergency department visits, reimbursement status, post-operative pain and opioid consumption, and length of hospital stay after surgery. This comprehensive monitoring helps assess the impact and safety of knee OA pain treatments over time.

Researchers are evaluating the effects of baxdrostat combined with dapagliflozin compared to dapagliflozin alone in adults aged 40 and older who have type 2 diabetes, established cardiovascular disease, a history of hypertension with systolic blood pressure of at least 130 mmHg at screening, and at least one additional risk factor for heart failure. This Phase III randomized, placebo-controlled, event-driven study aims to determine if the combination reduces the risk of heart failure events or cardiovascular death, with follow-up lasting up to 38 months. Participants who meet screening criteria but are not currently treated with SGLT2 inhibitors or have been treated for less than 4 weeks will enter a run-in period receiving dapagliflozin 10 mg once daily for 4 to 6 weeks before randomization. The study involves random assignment to either baxdrostat plus dapagliflozin or placebo plus dapagliflozin. Site visits occur at approximately 2, 4, 8, 16, and 34 weeks after randomization, then every 4 months. Participants discontinuing the blinded study drug may continue open-label dapagliflozin, with ongoing visits and data collection as per protocol. Participants will undergo an optional pre-screening period without site visits or consent to help identify eligibility, followed by up to 14 days of formal screening after informed consent. Researchers will monitor heart failure events and cardiovascular deaths as primary outcomes. Safety and adherence will be tracked throughout the study, including during any premature discontinuation of blinded treatment. The study will conclude when a predetermined number of secondary endpoint events have occurred, with continued follow-up as needed.

Researchers are evaluating the safety and effectiveness of the NeoThelium FT Amnion Skin Graft in treating diabetic foot ulcers. This prospective case series study involves participants with Type I or Type II diabetes who have diabetic foot ulcers of specific grades and sizes. The study is open-label, meaning both researchers and participants know the treatment being used. It aims to collect information useful for treatment evaluation and insurance reimbursement decisions. Participants will receive standard care plus weekly applications of NeoThelium FT, a dehydrated wound covering made from donated human placental tissue consisting of amnion and chorion layers. The treatment will continue according to a set schedule, with follow-ups as planned. This study is conducted across multiple medical centers and focuses on ulcers treated with specific offloading therapies prior to treatment. During the study, participants will be monitored for complete wound closure within 1 to 12 weeks. Researchers will assess the wound healing progress and ensure safety throughout the treatment period. Participants must meet specific health criteria and follow the study protocol, including regular visits and wound evaluations to track treatment outcomes.